MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030453
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, at the first firing to the root of inferior mesenteric artery during a laparoscopic low anterior resection procedure, the stapler did not fire.The display screen showed the indicator of the cartridge was ready for use.The surgeon re-clamped the tissue and pushed the green button then tried to fire the device, however he could not.They replaced the stapler with a new cartridge ,and the firing was completed with no problem.The sales rep noted that the staples did not appear from the staple pockets of the proximal end.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The loading unit was pre-fired and engaged in interlock.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Replication of the partial fire condition with interlock engagement may occur if the firing button had been partially compressed and then the open button was pressed after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the reload from firing a second time.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7362797
• Report Number: 1219930-2018-01594
• Device Sequence Number: 107049
• Product Code: GDW
• UDI-Device Identifier: 20884523002840
• UDI-Public: 20884523002840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 030453
• Device Catalogue Number: 030453
• Device Lot Number: N7E0998KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1